FDA Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry

标准简介

Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry[附网盘链接]是Food And Drug Administration发布的FDA标准，适用于美国。

标准截图

 

标准文档说明

标准文档类型为Data Integrity and Compliance With Drug CGMP Questions and Answers Guidance for Industry[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Data Integrity and Compliance With Drug CGMP Questions and Answers 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this guidance as listed on the title page. I. INTRODUCTION The purpose of this guidance is to clarify the role of data integrity in current good manufacturing practice (CGMP) for drugs, as required in 21 CFR parts 210, 211, and 212. Unless otherwise noted, the term CGMP in this guidance refers to CGMPs for drugs (including biologics). FDA’s authority for CGMP comes from section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Part 210 covers Current Good Manufacturing Practice in Manufacturing, Processing, Packing, or Holding of Drugs; General; part 211 covers Current Good Manufacturing Practice for Finished Pharmaceuticals; and part 212 covers Current Good Manufacturing Practice for Positron Emission Tomography (PET) Drugs. All citations to parts 211 and 212 in this document pertain to finished pharmaceuticals and PET drugs, but these requirements are also consistent with Agency guidance on CGMP for active pharmaceutical 2

ingredients with respect to data integrity. This guidance provides the Agency’s current thinking on the creation and handling of data in accordance with CGMP requirements. FDA expects that all data be reliable and accurate (see the “Background” section). CGMP regulations and guidance allow for flexible and risk-based strategies to prevent and detect data integrity issues. Firms should implement meaningful and effective strategies to manage their data integrity risks based on their process understanding and knowledge management of technologies 3

and business models. Meaningful and effective strategies should consider the design, operation, and monitoring of systems and controls based on risk to patient, process, and product. Management’s involvement 1

This guidance has been prepared by the Office of Pharmaceutical Quality and the Office of Compliance in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the Office of Regulatory Affairs at the Food and Drug Administration. 2

See the International Council for Harmonisation (ICH) guidance for industry Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. We update guidances periodically. To make sure you have the most recent version of a guidance, check the FDA Drugs guidance web page at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. 3

See ICH guidance for industry Q9 Quality Risk Management.

网盘链接

百度网盘：https://pan.baidu.com/s/12XeExnS4QcXVc1DdlEpmqQ
提取码：a4z4